BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1230272 · Received November 13, 2008

    Report

    Report Number
    2953200-2008-01055
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    July 27, 2008
    Report Date
    October 17, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS, CONCLUSIONS: (SPONTANEOUS GI BLEED). (SECONDARY INTERVENTION).

    Description of Event or Problem · 1

    FIVE ENDEAVOR SPRINT DRUG-ELUTING STENTS WERE IMPLANTED IN AN OVERLAPPING FASHION. (MFR REPORT# 29532000-2008-01053-01057). INVESTIGATOR REPORTED A SPONTANEOUS GI BLEED OCCURRED SIX DAYS LATER, WHILE ON ANTIPLATELET THERAPY. PT REQUIRED 5 UNITS OF AUTO-TRANSFUSION. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT. PT WAS ASYMPTOMATIC AT 30 DAY F/U.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000748733

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention